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The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Balance | Experimental | SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days |
|
| Systane Gel | Active Comparator | SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANE® BALANCE Lubricant Eye Drops | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort. | Baseline (Day 0), Day 14, Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abayomi Ogundele, PharmD | Alcon Research | Study Director |
| Penny A. Asbell, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
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A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54).
Subjects were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Balance | One drop in each eye 4 times a day for 30 days |
| FG001 | Systane Gel | One drop in each eye 4 times a day for 30 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This analysis group includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Balance | One drop in each eye 4 times a day for 30 days |
| BG001 | Systane Gel | One drop in each eye 4 times a day for 30 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 14, Day 30 |
|
Adverse events (AEs) were collected for the duration of the study (7 months). This analysis group includes all subjects exposed to the test product.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through volunteered and elicited comments from the subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Systane Balance | One drop in each eye 4 times a day for 30 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastasis to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| SYSTANE® Gel |
| Other |
|
| Baseline (Day 0), Day 14, Day 30 |
| Percentage of Eyes With Normal Slit-lamp Assessment | An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation. | Baseline (Day 0), Day 14, Day 30 |
| Meibomian Gland Expression | Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| Mean Change From Baseline in Ocular Surface Staining by Visit | Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 30 |
| Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. | Baseline (Day 0), Day 30 |
| Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. | Baseline (Day 0), Day 30 |
| Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean. | Baseline (Day 0), Day 14, Day 30 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop in each eye 4 times a day for 30 days
| OG001 | Systane Gel | One drop in each eye 4 times a day for 30 days |
|
|
| Secondary | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | LogMAR | Baseline (Day 0), Day 14, Day 30 |
|
|
|
| Secondary | Percentage of Eyes With Normal Slit-lamp Assessment | An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance. | Posted | Number | percentage of eyes | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Meibomian Gland Expression | Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | millimeters | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline in Ocular Surface Staining by Visit | Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Day 0), Day 30 |
|
|
|
| Secondary | Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. | Posted | Mean | Standard Deviation | percentage of cells | Baseline (Day 0), Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | percentage of cells | Baseline (Day 0), Day 30 |
|
|
|
| Secondary | Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | millimeters | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| Secondary | Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean. | This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 0), Day 14, Day 30 | eyes | eyes |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Systane Gel | One drop in each eye 4 times a day for 30 days | 1 | 27 | 0 | 27 |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| eyes |
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| Conjunctiva |
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| Cornea |
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| Anterior chamber |
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| Iris |
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| Lens |
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| Day 30, n=54, 54 |
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| eyes |
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| Conjunctival staining |
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| IL-6, n=24, 25 |
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| TNF-alpha, n=24, 25 |
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